Medline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF DYNJAAF6666B; b) ANESTHESIA CIRCUIT PEDS-LF, REF DYNJAP9918A; c) CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F
This recall is currently active, issued August 22, 2024. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- March 22, 2024
- Posted
- August 22, 2024
- Recall Number
- Z-2700-2024
- Quantity
- 1920 units
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
Lot / Code Info
a) REF DYNJAAF6666B, UDI/DI 40195327505838 (case), 10195327505837 (unit), Lot Numbers: 22EBD700, 22GBK692, 22KBE980, 23DBF522, 23GBU504, 23IBJ329, 23LBD558; b) REF DYNJAP9918A, UDI/DI 40195327505883 (case), 10195327505882 (unit), Lot Numbers: 22EBC460, 22HBK483, 22IBT280, 22JBC030, 22KBG647, 23IBM414; c) REF DYNJ905503F, UDI/DI 40889942131410 (case), 10889942131419 (unit), Lot Numbers: 22FBR267, 22GBR286, 22HBS560, 22IBA577, 22JBI883, 22KBD587, 22LBF425, 23BBN903, 23CBL450, 23CBW776, 23FBC209, 23IBU343, 23JBP494, 23KBH749, 23KBQ236
Root Cause
Under Investigation by firm
Action Taken
Medline Industries issued a Safety Alert to its consignees on 03/22/2024 via email and certified mail. The notice explained the problem with the device and requested that consignees follow the instructions for use. Distributors or those who further transferred the affected product were directed to notify their consignees.